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HEALTH NEWS

Inhaled Insulin Powder on Track for FDA Approval

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Contributed by William Angelos|  03 March, 2005  17:07 GMT

pfizer insulin exubera FDA
More than half of people with diabetes remain uncontrolled or poorly controlled and are at risk for common complications, such as heart disease, stroke, kidney failure, nerve damage and blindness.
The US Food and Drug Administration (FDA) accepted for filing a new drug application for Exubera, an inhaled human insulin powder, Pfizer and the Sanofi-Aventis Group announced today. The drug is intended for adults with type 1 and 2 diabetes.

Exubera is inhaled into the lungs prior to eating, using a specially designed inhalation device. It has been studied in more than 3,500 patients, some for over seven years, the companies report.

Exubera is currently under review by the European Medicines Evaluation Agency.

Diabetes Expected to Skyrocket

An estimated 180 million people worldwide suffer from diabetes, and the number is expected to rise to 300 million people in the next 20 years.

More than half of people with diabetes remain uncontrolled or poorly controlled and are at risk for common complications, such as heart disease, stroke, kidney failure, nerve damage and blindness, according to the companies.

Diabetes and its complications account for more than $100 billion in healthcare costs annually in the United States.

Global Agreement

Exubera is being developed through a collaboration between Pfizer and Sanofi-Aventis. The two companies have entered into a global agreement to co-develop, co-promote (where permitted by local law) and co-manufacture inhaled insulin.

Pfizer is also in collaboration with Nektar Therapeutics, developers of the inhalation device and formulation.

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